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Bioequivalent estradiol patch approved for new indication dose

September 27, 2014

The FDA has approved a 33% smaller dose of the estradiol transdermal system for the prevention of postmenopausal osteoporosis, according to the manufacturer.

Minivelle (estradiol transdermal system, Noven Pharmaceuticals) is bioequivalent to Vivelle (estradiol transdermal system, Novartis AG) and was previously approved in 2012 for the treatment of vasomotor symptoms. That approval was for a dime-sized patch of 0.0375 mg/day. In this iteration, expected in 2015, Minivelle will be available in a 0.025 mg/day patch, which will be approximately 33% smaller and approved only for the prevention of postmenopausal osteoporosis, according to the release.

Meeting News Coverage

Denosumab shows promise for osteoporotic women at high risk for fracture

September 23, 2014
Women with osteoporosis who are at high risk for fracture adhered to denosumab therapy better than other osteoporosis treatments over time, according to research…
figure Meeting News Coverage

Vitamin D therapy improved deficiency rates of middle-aged women

September 22, 2014
Supplements containing vitamin D helped women of varying race, ethnicity, socioeconomic status and education levels increase their long-term levels of 25-hydroxyvitamin…
Meeting News Coverage

Vitamin K supplements failed to improve BMD in postmenopausal osteopenia

September 19, 2014
Women with osteopenia after menopause demonstrating low vitamin K1 concentrations did not improve bone mineral density with long-term vitamin K1 supplements for the…
CME
figure

Experts’ Take: Dialogue on Hypertriglyceridemia

This activity is supported by an independent educational grant from Amarin Pharma Inc.

Lead by genetic studies, recent data describe a causal role of triglycerides (TG) in the formation of atherosclerosis…
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CME
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Screening and Treatment of Diabetes-Associated Eye Disease: Out of Sight, Out of Mind?

This activity is supported by an educational grant from Regeneron Pharmaceuticals, Inc.

Diabetic retinopathy is a major cause of blindness among adults aged 40 years and older. Optimal outcomes necessitates…
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FDA News

Bioequivalent estradiol patch approved for new indication dose

September 27, 2014
The FDA has approved a 33% smaller dose of the estradiol transdermal system for the prevention of postmenopausal osteoporosis, according to the…
Meeting News Coverage

Denosumab shows promise for osteoporotic women at high risk for fracture

September 23, 2014
Women with osteoporosis who are at high risk for fracture adhered to denosumab therapy better than other osteoporosis treatments over time, according…
figure Meeting News Coverage

Vitamin D therapy improved deficiency rates of middle-aged women

September 22, 2014
Supplements containing vitamin D helped women of varying race, ethnicity, socioeconomic status and education levels increase their long-term levels…
Meeting News Coverage

Vitamin K supplements failed to improve BMD in postmenopausal osteopenia

September 19, 2014
Women with osteopenia after menopause demonstrating low vitamin K1 concentrations did not improve bone mineral density with long-term vitamin K1…
figure Meeting News Coverage

Diabetes increased risk for major osteoporotic, hip fracture

September 17, 2014
Diabetes is a stand-alone risk factor for major osteoporotic fractures but does not alter the effect of Fracture Risk Assessment Tool risk factors or…
figure Meeting News Coverage

Cortical bone microstructure, tibia density deficits seen with type 2 diabetes, high HbA1c

September 16, 2014
Type 2 diabetes and increased HbA1c are associated with deficits in cortical bone microstructure and bone density at the distal tibia, according to…
figure Meeting News Coverage

Bone mineral density score disparity highlights need to redefine osteoporosis in children

September 15, 2014
Defining pediatric osteoporosis based on lumbar spine-bone mineral density z score may be problematic due to differences in reference databases and…
figure Meeting News Coverage

Transcellular calcium uptake decreased after Roux-en-Y gastric bypass surgery

September 15, 2014
Fractional transcellular calcium uptake decreased after Roux-en-Y gastric bypass surgery, even with maintenance of serum 25-hydroxyvitamin D levels…
figure Meeting News Coverage

Children, adults with autism spectrum disorder at increased risk for hip fracture

September 15, 2014
Adults and children with autism spectrum disorder have lower bone mineral density, putting them at higher risk for fractures, particularly of the…
figure In the Journals

Bisphosphonate treatment did not reduce risk for postmenopausal breast cancer

August 21, 2014
Treatment with bisphosphonates for osteoporosis provided no protective effect against the risk for invasive postmenopausal breast cancer, according…
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